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TAG September 21, 2018 0 Comments

If you are selling produce or using produce you need to keep Cyclospora in mind because the FDA Commissioner certainly has it on his mind. In March, we warned readers about FDA’s increased focus on spices and herbs (If You Use or Sell Spices Watch Out! You are on FDA’s Radar… and Your Fresh Herbs and Avocado Products May Be Part of FDA’s Increased Sampling). We are now beginning to see the results of that focus, particularly in the agency’s sampling of herbs, with FDA findings this summer including that of both domestic and imported cilantro testing positive for Cyclospora. In one case, two samples of cilantro offered for import from two producers in Mexico were found to be positive for Cyclospora. In response, FDA refused entry for the shipments, and is taking action to prevent contaminated cilantro from those firms from entering the U.S. Additionally, through the FDA Produce Safety Partnership with Mexico, the two countries are working together to investigate the cause. Additionally, a domestic cilantro sample collected at a distributor in July tested positive for Cyclospora. Upon further investigation, another sample was collected on the farm that also tested positive. In response, FDA worked closely with state officials to voluntarily recall and embargo potentially affected product, and has been working with the farmer on corrective actions geared toward common routes of contamination. In neither case was there a link established with any illnesses, nor has there been any indication of a connection between the contaminated cilantro and the multistate outbreaks of Cyclospora illnesses that have been investigated this spring and summer. FDA’s sampling is a part of a robust sampling program the agency began in 2014 to assess microbial contamination in food commodities. Under the new approach, FDA collects a statistically valid number of samples of targeted foods over 12-18 months to identify common factors among positive findings. Recently the agency added a newly developed and validated analytical testing method for Cyclospora cayetanensis because the parasite has caused outbreaks in the U.S. linked to imported produce grown under insanitary conditions. Fresh herbs, specifically basil, parsley, and cilantro, have gotten particular attention from FDA because they are typically eaten without having undergone a kill step and are grown low to the ground, making them susceptible to contamination. The program also has focused on sprouts, whole fresh avocados, and raw milk cheese – with FDA collecting more than 800 samples of each commodity and tested them for Salmonella, Listeria monocytogenes and E. coli O157:H7; on cucumbers and hot peppers for Salmonella and E. coli O157:H7, taking 1,600 samples of each commodity; and hot peppers for Shiga toxin producing E. coli; and processed avocado and guacamole to test for Salmonella and Listeria monocytogenes. The sampling of basil, parsley, and cilantro also includes testing for Salmonella and Shiga toxin producing E. coli. So what does all this mean to you? As we said in March, anyone producing or using any of these is on FDA’s radar! And that radar, as specifically noted by FDA, will be conducted through “whole genomic sequence testing (WGS) on any samples that test positive.” – at least for those pathogens that FDA has WGS technology for which so far does not seem to include Cyclospora. With WGS able to link much more extensively through time and geography than even before, that radar becomes more intensive with each sample that is tested. But what I see as even more important than that is the realization that these foods may be more susceptible to contamination than has been previously realized – or guarded against. So, in my view, the real meaning is that all suppliers, manufacturers, and processors should take a new look at their risk assessments and preventive controls to ensure that any ingredients or finished products without a kill step – particularly herbs, spices, avocados, sprouts, raw milk cheese, cucumbers, and hot peppers – are being assessed for risk, and effective preventive controls are put in place and being validated. Some of these, such as spices, have been known sources of microbiological problems – with 1 in 200 retail samples of ground coriander, ground red pepper, and dehydrated garlic testing positive for Salmonella. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain.  With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. Learn more at:


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